The purpose of this FIH study is to evaluate the safety, tolerability and pharmacokinetics of ONO-2020 in healthy adult participants. This FIH study consists of five parts (Parts A-E) to study single or multiple doses of ONO-2020 in healthy participants, including elderly and Japanese participants, as well as the food effect on the PK of ONO-2020. These data will support the clinical development program and help inform dose selection in future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Altasciences
Cypress, California, United States
Incidence, severity, and type of treatment emergent adverse events (TEAEs)
Incidence of TEAEs will be summarized overall, and by study part and dose group using frequency and percentage.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Vital signs (blood pressure)
Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Vital signs (pulse rate)
Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Vital signs (body temperature)
Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Vital signs (respiratory rate)
Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
12-lead electrocardiograms (ECGs) parameters, such as but not limited to heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF)
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The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of ECG results will be tabulated at each time point.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Clinically significant abnormal telemetry electrocardiograms (ECGs)
The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of telemetry ECGs results will be tabulated at each time point.
Time frame: Part A and D: Day 1
Clinically significant abnormal physical examination findings
The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of physical examination results will be tabulated at each time point.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Clinical laboratory abnormalities (hematology, clinical chemistry, coagulation, and urinalysis)
The number and percentage of subjects with abnormal laboratory results at any time during the study will be tabulated.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Ophthalmologic examination findings (pupil size and pupillary light reflex)
The number and percentage of subjects with miosis will be summarized by laterality at each time point.
Time frame: Part A, C and D: From Day 1 up to Day 7, Part B and E: From Day 1 up to Day 21
Clinically abnormal findings in Mini-International Neuropsychiatric Interview Screen (M.I.N.I.-Screen)
Responses to the M.I.N.I.-Screen will be listed.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Clinically abnormal findings in Columbia Suicide Severity Rating Scale (C-SSRS)
Responses to the suicidality assessment scale (C-SSRS) will be listed.
Time frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21
Pharmacokinetics (Cmax in plasma)
Time frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19
Pharmacokinetics (Tmax in plasma)
Time frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19
Pharmacokinetics (AUClast in plasma)
Time frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19
Pharmacokinetics (AUCinf in plasma)
Time frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19
Pharmacokinetics (T1/2 in plasma)
Time frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19
Pharmacokinetics (CL/F in plasma)
Time frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19
Pharmacokinetics (Aet in urine)
Time frame: Part A and D: Day 1 through Day 4
Pharmacokinetics (fe/F in urine)
Time frame: Part A and D: Day 1 through Day 4
Pharmacokinetics (CLR in urine)
Time frame: Part A and D: Day 1 through Day 4
Pharmacokinetics (Ctrough in plasma)
Time frame: Part B and E: Day 2 through Day 13
Pharmacokinetics (ONO-2020 concentration in CSF)
Time frame: Part C: Day 2